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| ID | Type | Description | Link |
|---|---|---|---|
| 90876777 | Other Identifier | BSC protocol number |
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To compile characteristics of real-world clinical outcomes for Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice, when used according to the applicable Instructions for Use
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To evaluate the economic value and technical performance of Boston Scientific commercially approved neurostimulation systems for pain in routine clinical practice
The study is a prospective, multi-center, global, post-market study of Boston Scientific neurostimulation systems for pain.
The study treatment will consist of neurostimulation trial therapy with any commercially approved Boston Scientific Corporation neurostimulator for pain. Positive trials, subjects with a successful trial outcome, may progress to permanent implant of a neurostimulation system. Individualization of neurostimulation therapy for pain will be determined according to investigator discretion and site routine care, and in accordance with inclusion and exclusion criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Boston Scientific SCS Systems | Subjects permanently implanted with a Boston Scientific neurostimulation systems |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neurostimulation system | Device | Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Percent Pain Relief | Percent pain relief of targeted pain at 6, 12, 24, 36, 48, and 60 months follow up | Up to 60 months follow up |
| Percent Pain Relief | Percent pain relief of low back pain at 6, 12, 24, 36, 48, and 60 months follow up |
Key Inclusion Criteria:
Key Exclusion Criteria:
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Subjects who exhibit an on-label indication for neurostimulation to relieve chronic intractable pain, according to the Instructions for Use, as applicable in each country or region
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thanh Hoang, MS | Contact | 855-213-9890 | BSNClinicalTrials@bsci.com | |
| Stephanie Delvaux | Contact | 855-213-9890 | BSNClinicalTrials@bsci.com |
| Name | Affiliation | Role |
|---|---|---|
| Natalie Bloom Lyons | Boston Scientific Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Research Group, LLC | Terminated | Phoenix | Arizona | 85016 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36691862 | Derived | Rauck RL, Loudermilk E, Thomson SJ, Paz-Solis JF, Bojrab L, Noles J, Vesper J, Atallah J, Roth D, Hegarty J, Prud'Homme M, Phillips GM, Smith SG, Ibrahim M, Willoughby CD, Obray JB, Gupta M, Paez J, Berg AP, Harrison NJ, Maino P, Mambalam P, McCarty M, Towlerton G, Love-Jones S, Ahmed S, Lee A, Shah B, Goor-Aryeh I, Russo MA, Varela N, Phelps JB, Cid J, Fernandez T, Perez-Hernandez C, Keehn D, Rosenow JM, Haider N, Parrent AG, Lawrence MM, Georgius P, Demartini L, Mendiola A, Mehta V, Thoma R, Israel AF, Carolis G, Bhatia S, Green M, Villarreal A, Crooks MT, Gwinn RP, Pilitsis JG, Sato H, Vega SM, Hillegass MG, Carnes P, Scherer C, Brill S, Yu J, Brennan JJ, Gatzinsky K, Navani A, Snook LT Jr, Bujedo BM, Andres Ares J, Murillo A, Trobridge AT, Assil K, Shah J, McLeod C, Buwembo J, Coster O, Miller N, Sanapati M, Mikhael M, Przkora R, Sukenaga N, Raso LJ, Calodney AK, Caceres Jerez LE, Uchiyama T, Kallewaard JW, Chandler B, Piedimonte F, Candido KD, Weaver TE, Agari T, Holthouse D, Woon R, Patel N, Lechleiter K, Jain R. Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. Pain Manag. 2023 Feb;13(2):115-127. doi: 10.2217/pmt-2022-0091. Epub 2023 Jan 24. |
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| Up to 60 months follow up |
| Percent Pain Relief | Percent pain relief of leg pain at 6, 12, 24, 36, 48, and 60 months follow up | Up to 60 months follow up |
| Change in QoL | Change in quality of life as reported by the Subject at | Up to 60 months follow up |
| Hope Research Institute |
| Terminated |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Banner University Medical Center | Completed | Tucson | Arizona | 85724 | United States |
| Comprehensive Pain Management Center | Terminated | Campbell | California | 95008 | United States |
| Coastal Research Institute | Terminated | Carlsbad | California | 92009 | United States |
| Pain Medicine Associates, Inc. | Terminated | Fountain Valley | California | 92708 | United States |
| Metropolitan Pain Management Consultants Inc. | Terminated | Sacramento | California | 95821 | United States |
| Huntley Pain Specialists | Withdrawn | San Diego | California | 92108 | United States |
| Conejo Pain Specialists | Terminated | Thousand Oaks | California | 91362 | United States |
| Denver Back Pain Specialists | Recruiting | Greenwood Village | Colorado | 80111 | United States |
|
| Orlando Health Neuroscience Institute, Inc | Recruiting | Clermont | Florida | 34711 | United States |
|
| South Lake Pain Institute, Inc | Recruiting | Clermont | Florida | 34711 | United States |
|
| University of Florida Shands Hospital | Recruiting | Gainesville | Florida | 32608 | United States |
|
| Louis J. Raso, MD, PA | Terminated | Jupiter | Florida | 33477 | United States |
| Advanced Interventional Pain Management and Research Clinic, Inc. | Terminated | Miami Gardens | Florida | 33169 | United States |
| JM Clinical Research | Withdrawn | South Miami | Florida | 33143 | United States |
| Tallahassee Neurological Clinic, PA | Terminated | Tallahassee | Florida | 32308 | United States |
| Orthopedic Research Foundation | Terminated | Savannah | Georgia | 31405 | United States |
| Pain Care, LLC | Withdrawn | Stockbridge | Georgia | 30281 | United States |
| Northwestern Memorial Hospital - Neurosurgery Outpatient Clinic | Terminated | Chicago | Illinois | 60611 | United States |
| Chicago Anesthesia Pain Specialists | Terminated | Chicago | Illinois | 60657 | United States |
| Global Scientific Innovations - Advanced Pain Care Clinic | Terminated | Evansville | Indiana | 47714 | United States |
| Summit Research Institute | Terminated | Fort Wayne | Indiana | 46825 | United States |
| Goodman Campbell Brain and Spine | Withdrawn | Greenwood | Indiana | 46143 | United States |
| American Health Network of Indiana, LLC | Terminated | Muncie | Indiana | 47304 | United States |
| Research Medical Center | Terminated | Lenexa | Kansas | 66214 | United States |
| Neuroscience Associates of Northern Kentucky | Withdrawn | Crestview Hills | Kentucky | 41017 | United States |
| Bux Pain Management | Terminated | Danville | Kentucky | 40422 | United States |
| Ochsner Clinic Foundation | Recruiting | New Orleans | Louisiana | 70115 | United States |
|
| Willis-Knighton River Cities Clinical Research Center | Recruiting | Shreveport | Louisiana | 71105 | United States |
|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| Beth Israel Deaconess Medical Center | Terminated | Brookline | Massachusetts | 02445 | United States |
| Michigan Pain Specialists | Terminated | Ann Arbor | Michigan | 48108 | United States |
| Insight Institute of Neurosurgery & Neuroscience | Terminated | Flint | Michigan | 48507 | United States |
| Forest Health Medical Center | Terminated | Ypsilanti | Michigan | 48198 | United States |
| Jackson Anesthesia Pain Center, LLC | Terminated | Jackson | Mississippi | 39202 | United States |
| Midwest Pain Center | Terminated | Chesterfield | Missouri | 63005 | United States |
| Saint Louis Pain Consultants | Terminated | Chesterfield | Missouri | 63017 | United States |
| KC Pain Centers | Terminated | Lee's Summit | Missouri | 64086 | United States |
| Hope Research Institute | Withdrawn | Las Vegas | Nevada | 89106 | United States |
| Albany Medical Center | Terminated | Albany | New York | 12208 | United States |
| New York Presbyterian Hospital | Terminated | New York | New York | 10065 | United States |
| University of Rochester | Terminated | Rochester | New York | 14618 | United States |
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10461 | United States |
|
| Spine and Skeletal Pain Medicine | Terminated | Utica | New York | 13502 | United States |
| Carolinas Research Institute, PLLC | Terminated | Huntersville | North Carolina | 28078 | United States |
| Raleigh Neurology Associates, P.A. | Terminated | Raleigh | North Carolina | 27607 | United States |
| The Center for Clinical Research, LLC | Terminated | Winston-Salem | North Carolina | 27103 | United States |
| Case Western Reserve University | Completed | Cleveland | Ohio | 44106 | United States |
| Ohio State University Medical Center | Terminated | Columbus | Ohio | 43203 | United States |
| University of Toledo Medical Center | Terminated | Toledo | Ohio | 43614 | United States |
| Pacific Sports and Spine, LLC | Recruiting | Eugene | Oregon | 97401 | United States |
|
| Fox Chase Pain Management | Recruiting | Trevose | Pennsylvania | 19053 | United States |
|
| Medical University of South Carolina | Terminated | Charleston | South Carolina | 29425 | United States |
| Florence Neurosurgery and Spine | Terminated | Florence | South Carolina | 29506 | United States |
| PCPMG Clinical Research Unit, LLC | Recruiting | Greenville | South Carolina | 29601 | United States |
|
| Channel Research | Terminated | Pawleys Island | South Carolina | 29585 | United States |
| Balcones Pain Consultants | Terminated | Austin | Texas | 78745 | United States |
| Institute of Precision Pain Medicine | Recruiting | Corpus Christi | Texas | 78414 | United States |
|
| Spine Works Institute | Terminated | North Richland Hills | Texas | 76182 | United States |
| Spine Team Texas | Terminated | Rockwall | Texas | 75032 | United States |
| Precision Spine Care | Terminated | Tyler | Texas | 75701 | United States |
| Washington Center for Pain Management | Terminated | Bellevue | Washington | 98004 | United States |
| EvergreenHealth Pain Care | Withdrawn | Kirkland | Washington | 98034 | United States |
| Swedish Neuroscience Institute | Terminated | Seattle | Washington | 98122 | United States |
| West Virginia University Hospitals | Withdrawn | Morgantown | West Virginia | 26506 | United States |
| Advanced Pain Management Appleton | Terminated | Greenfield | Wisconsin | 53221 | United States |
| CENIT Centro de Neurociencias, Investigacion y Tratamiento | Terminated | Buenos Aires | Argentina |
| Interventus Pain Specialists | Withdrawn | Auchenflower | Australia |
| Hunter Clinical Research | Terminated | Broadmeadow | Australia |
| Hunter Pain Clinic | Terminated | Broadmeadow | Australia |
| Green Lizard Science | Terminated | Claremont | Australia |
| Sydney Spine and Pain Pty Ltd | Terminated | Hurstville | Australia |
| Sunshine Coast Clinical Research | Terminated | Noosa | Australia |
| Pain Matrix | Terminated | Waurn Ponds | Australia |
| Pain Medicine of South Australia | Recruiting | Wayville | Australia |
|
| AZ Sint-Lucas | Withdrawn | Ghent | Belgium |
| AZ Delta | Terminated | Roeselare | Belgium |
| London Health Sciences Centre | Terminated | London | Canada |
| Hopital de Enfant-Jesus | Recruiting | Québec | Canada |
|
| Regina General Hospital | Recruiting | Regina | Canada |
|
| Fundacion Clinica Valle del Lili | Withdrawn | Cali | Colombia |
| Fundacion Cardiovascular de Colombia Floridablanca | Terminated | Floridablanca | Colombia |
| Odense University Hospital | Terminated | Odense | Denmark |
| Universitatsklinik Charite Berlin | Recruiting | Berlin | Germany |
|
| University KH Bonn | Terminated | Bonn | Germany |
| Uniklinik Köln | Terminated | Cologne | Germany |
| Uniklinik Köln | Recruiting | Cologne | Germany |
|
| Universitaetsklinikum Dusseldorf | Recruiting | Düsseldorf | Germany |
|
| Algesiologikum | Terminated | München | Germany |
| Sheba Medical Center | Terminated | Ramat Gan | Israel |
| Tel Aviv Sourasky Medical Center | Terminated | Tel Aviv | Israel |
| Fondazione Salvatore Maugeri IRCCS | Recruiting | Pavia | Italy |
|
| Azienda Ospedaliero Universitaria Pisana | Terminated | Pisa | Italy |
| Kobe University Hospital | Terminated | Kobe | Japan |
| Hyogo College of Medicine Hospital | Terminated | Nishinomiya-shi | Japan |
| Okayama University Hospital | Terminated | Okayama | Japan |
| Sakai Hospital Kinki University Faculty of Medicine | Terminated | Sakaishi | Japan |
| Ziekenhuis Rijnstate | Terminated | Velp | Netherlands |
| Hospital General de Ciudad Real | Recruiting | Ciudad Real | Spain |
|
| Hospital La Paz | Terminated | Madrid | Spain |
| Hospital La Princesa | Terminated | Madrid | Spain |
| Hospital Puerta de Hierro | Recruiting | Madrid | Spain |
|
| Hospital Universitario Infanta Elena | Withdrawn | Madrid | Spain |
| Clinica Universidad de Navarra | Recruiting | Pamplona | Spain |
|
| Hospital Donostia | Active, not recruiting | San Sebastián | Spain |
| H. Marques De Valdecilla | Terminated | Santander | Spain |
| Hospital Virgen De La Salud | Terminated | Toledo | Spain |
| Hospital General de Valencia | Recruiting | Valencia | Spain |
|
| Sahlgrenska University Hospital | Terminated | Gothenburg | Sweden |
| Ospedale Regionale di Lugano | Terminated | Viganello | Switzerland |
| Basildon and Thurrock University Hospitals NHS | Recruiting | Basildon | United Kingdom |
|
| Southmead Hospital Bristol | Recruiting | Bristol | United Kingdom |
|
| The General Infirmary | Recruiting | Leeds | United Kingdom |
|
| Chelsea and Westminster Hospital | Terminated | London | United Kingdom |
| St. Bartholomews Hospital | Recruiting | London | United Kingdom |
|
| James Cook University Hospital | Recruiting | Middlesbrough | United Kingdom |
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| Royal National Orthopaedic Hospital | Terminated | Stanmore | United Kingdom |
| ID | Term |
|---|---|
| D010146 | Pain |
| D001416 | Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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